CE Mark

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St. Jude Medical's transcatheter aortic valve replacement, or TAVR, cardiology device is now commercially available in Europe once again, after its CE mark was suspended following safety concerns about reduced valve leaflet mobility arising from the company's U.S. clinical trials.

Covidien today announced the CE mark granted for its Stellarex drug-coated balloon for peripheral artery disease. In addition to physically displacing the lesion with angiopolasty, Stellarex delivers the drug paclitaxel like many of its European competitors.

Roche has launched the Laboratory-in-a-tube technology it acquired when it bought iQuum in April for $275 million up front and up to $175 million in milestone payments. Roche is making the system available in the U.S. and Europe.

Micro-cap obesity device company GI Dynamics is restructuring by cutting 10% of its workforce, including its CFO, as well as reviewing its strategic options. The Australian company expects to communicate its next move "over the next several months," GI Dynamics' president and CEO, Michael Dale, said in a statement.

Edwards Lifesciences led a $50 million financing for catheter-based heart failure treatment startup CardioKinetix. The cash is expected to enable the completion of an ongoing U.S. pivotal trial for the company's Parachute Ventricular Partitioning Device with a PMA submission to the FDA to follow, as well as to finance international marketing efforts.

iRhythm has received a CE mark in Europe for its continuous heart monitoring Zio Service. The technology enables up to 14 days of continuous heart monitoring via a wireless patch; it includes analytical software, as well as report to the physician. In addition, iRhythm has partnered with cardiology distributor CardioLogic to market Zio in the U.K. for the diagnosis of atrial fibrillation and other cardiac arrhythmias.

Reva Medical has raised $25 million in debt from Goldman Sachs and Senrigan Capital. The financing had been months in the making and is expected to enable the development-stage company to get its latest bioresorbable stent on the market in Europe.

Medtronic kicked off the commercialization of its Resolute Onyx drug-eluting stent in Europe today. The device will also be launched in selected countries around the world that recognize the CE mark, but not the U.S., where FDA approval is required.